Pharmaceutical Serialization 101
- Coming soon!
Serialization touches every corner of the pharmaceutical supply chain. From legal and compliance to IT, operations, quality, and business development, each team faces different requirements across global markets; and misalignment can be costly.
Empower your workforce to work smarter, not harder.
Say goodbye to costly misunderstandings and delays. Say hello to faster delivery, sharper execution, and greater efficiency.
Pharmaceutical Serialization 101 is a modular, accessible eLearning program designed to upskill cross‑functional teams and build a shared foundation of knowledge. Covering global serialization concepts, the USA’s DSCSA, and the EU FMD, this course gives professionals across the pharma ecosystem the clarity they need to operate with confidence.
Equip your organisation to work smarter.
Pharmaceutical Serialization 101 breaks down complex regulations, demystifies technical processes, and creates a common language across departments and partners. The result: faster decision‑making, fewer misunderstandings, smoother collaboration, and stronger compliance.
This isn’t just training—it’s a strategic upgrade.
Give your workforce the insight to anticipate challenges, streamline communication, and deliver with precision. When everyone understands serialization, everything moves faster.
Overview
A comprehensive introduction to the legal requirements and business impacts of the US DSCSA, European Union's Falsified Medicine Directive and more.
Multiple global requirements
There's no unified standard for pharmaceutical serialization: regulations, timelines and systems vary across the globe.
The United States' Drug Supply Chain Security Act (DSCSA) and the European Union's Falsified Medicine Directive present two very different approaches to safeguarding patients. Across the globe, there are many other regimes in force, with even more on the way.
Operational complexity
Putting pharmaceutical serialization into practice is complex: it requires multiple functions at every organisation in the pharmaceutical supply chain.
Serialization requires an overall business strategy that considers all the organisational, and cross-organisational implications.
How Pharmaceutical Serialization 101 will help:
Pharmaceutical Serialization 101 provides a high-level overview of pharmaceutical serialization. We’ll cover:
- the key regulations driving its implementation
- the technical systems that make it work; and
- how all this impacts operations.
Modules and timings
We offer three clear, concise modules covering different pharmaceutical serialization topics.
Pick the right solution for your organisation: Module 1 + Module 2 and/or Module 3:
Module 1
Introduction to Pharmaceutical Serialization
The core principle of pharmaceutical serialisation - unique identification - is universal, but it’s not the whole story. Serialization provides the foundations for a range of other processes, including:
- tracking and tracing
- verifying
- reporting
Approx. 15 minutes
Module 2
The United States: the DSCSA
The United States' Drug Supply Chain Security Act (DSCSA) establishes an enterprise-run, transaction-focused approach that tracks and traces prescription drugs as they move through the supply chain, particularly when they change ownership.
Approx. 15 minutes
Module 3
Europe: the EU Falsified Medicines Directive
The European Union's Falsified Medicines Directive (EUFMD) requires serialization of prescription drugs, to establish near real-time verification against a centralised repository system.
Approx. 15 minutes
Who's it for?
Pharmaceutical serialization touches many roles across the supply chain:
Organisations
Organisations who need to master pharmaceutical serialization include:
- Pharmaceutical companies
- Manufacturers
- Contract Manufacturing Organisations (CMOs)
- Third-Party Logistics Providers (3PLs)
- Wholesalers
- Distributors
- Dispensers, such as hospitals and pharmacies
People
People with a role to play in pharmaceutical serialization include:
- IT
- Regulatory and Compliance
- Supply Chain Management
- Data Management and Analytics
- Operations
- Packaging
- Quality
- Business Development
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